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Sponsored by: |
National Institute on Drug Abuse (NIDA) |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00129272 |
Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.
Condition | Intervention | Phase |
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Tobacco Use Cessation Tobacco Use Disorder |
Drug: Bupropion Drug: Placebo Behavioral: CBT Treatment |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Stress Response and Smoking Cessation in Depressed Youth |
Estimated Enrollment: | 150 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Participants who will be placed in the active medication treatment group
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Drug: Bupropion
150mg tablets taken orally twice daily.
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2: Placebo Comparator
Participants who will be placed in the placebo treatment group
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Drug: Placebo
Participants will receive placebo in this treatment group.
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3: Experimental
Participants who will receive cognitive behavioral treatment only
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Behavioral: CBT Treatment
Participants will undergo nine weeks of behavioral modification therapy only.
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Cigarette smoking and other forms of tobacco exposure are one of the leading preventable causes of morbidity and mortality in the United States. Most smokers begin smoking during adolescence, and though they seem motivated to quit smoking, they frequently fail. Although behavioral treatments are available, they have not been very successful in past studies.
Depressed adults may have more difficulty quitting smoking than non depressed adults; this finding may also apply to depressed youth. The purpose of this study is to determine the effectiveness of bupropion in combination with standard behavioral treatment in helping young smokers quit, as compared to behavioral treatment alone. Finally, the study examines whether hormonal response to stress measured prior to treatment initiation predicts whether individuals respond well to treatment with bupropion.
Participants in this double-blind study will be randomly assigned to receive either bupropion or placebo. Both groups will receive behavioral treatment. The trial will last for 9 weeks, with weekly study visits. Study visits will last 30 minutes to 1 hour and will include medication monitoring, self-reported and biological measures of smoking, and behavioral treatment. Participants will have follow-up visits six months after completion of treatment and at yearly intervals for up to 4 years.
Ages Eligible for Study: | 12 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thomas Gibbs, BA | 214-648-5250 | thomas.gibbs@utsouthwestern.edu |
United States, Texas | |
University of Texas Southwestern Medical Center | Recruiting |
Dallas, Texas, United States, 75390 9101 | |
Contact: Thomas Gibbs, BA 214-648-5250 teenhealth@utsouthwestern.edu |
Principal Investigator: | Uma Rao, MD | University of Texas Medical Center |
Responsible Party: | University of Texas Southwestern Medical Center ( Dr. Uma Rao, M.D. ) |
Study ID Numbers: | NIDA-15131-1, R01-15131-1, DPMC |
Study First Received: | August 4, 2005 |
Last Updated: | July 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00129272 |
Health Authority: | United States: Federal Government |
Nicotine polacrilex Smoking Dopamine Depression Nicotine Mental Disorders |
Tobacco Use Disorder Bupropion Substance-Related Disorders Disorders of Environmental Origin Stress |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |